Dimension Vista Carbon Dioxide, Creatinine and Lactate Dehydrogenase Flex Reagent Cartridge

• • Terminated Z-2741-2015 FDA Class II ·initiated 15 Jul 2015 ·on shared 510(k) K061238

  Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results up to - 12.7% and -22% respectively, for a creatinine concentration of 1.5 mg/dL when hemolysis exceeds 200 mg/dL and 300 mg/dL respectively.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K061238 ↗

FDA Product Code

KHS

Device Class

Class II

Regulation

21 CFR Part 862.1160

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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